Presented at Foundry Health's eSource meeting in Chicago, 03-Oct-2017

1. ECG Interoperability and
Industry Trends
Justin L. Mortara, Ph.D.
October 3rd, 2017

2. Page 1
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED
About Mortara
Products incorporating ECG expertise into continuous
real time monitoring for Phase 1 Units, Cardiac Rehab, and
Cardiology.
üAmbulatory Telemetry
üBedside Monitors
üCentral Stations
üClinical IT Solutions
Patient Monitoring
Products used in the non-invasive diagnosis of
cardiovascular disease and cardiac safety profile of new
drugs.
üResting ECG
üStress Exercise
üHolter/ABPM Monitoring
üECG Management
Diagnostic Cardiology
Mortara Instrument
• Leading provider of Diagnostic Cardiology (ELI™
electrocardiographs) and Cardiology Monitoring
(Surveyor™) device solutions.
• Recognized technology leader in ECG algorithms with
VERITAS™.
• Number 1 provider of ECG devices used in clinical
trials and technology partner with FDA on ECG
Warehouse.
• Acquired by Hill-Rom in early 2017. Now the
cardiology product engine for Front Line Care division.

3. ECG Interoperability and
Industry Trends
Justin L. Mortara, Ph.D.
October 3rd, 2017
Device

4. Page 3
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED
Interoperability definition
Different devices interoperating with different IT solutions.

5. Page 4
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED
The Path from Proprietary to Interoperability in ECG
Data Exchanged
Interoperability
Results
Outbound
+ Demographics
Inbound
+ Workflow
Triggers
Proprietary
Systems
Open
Architecture
Full
Interoperability
Subject ID:
<Capture ECG
Now>
Defined API
Defined XML Schema
“Readable” XML data
Closed Standards BasedCooperative

6. Page 5
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED
Case Study: HL7 annotated ECG Standard (2001-04)
Challenge Solution
ECGs collected in clinical trials were largely paper-based.
FDA wanted digital solution as means to review both
original ECG data as well as annotations made by ECG
central laboratories. No data standard existed to
support this.
Ad hoc group consisting of regulators, sponsors, ECG
central labs and device manufacturers collaborated to
create the HL7 Annotated ECG standard. Standard
broadly utilized now for results reporting and uploading
into FDA ECG Warehouse.
Today multiple devices from various vendors are used to collect ECG data with output in conformance with the
HL7 aECG standard. To date over 10,000,000 ECGs have been imported into the FDA ECG Warehouse.
Mortara, GE, Philips
individual
XML “flavors”
Paper based ECGs
or proprietary
digital data.

7. Page 6
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED
Look Ahead – some general trends and challenges!
Demand for connected
devices increases
Information integration,
reduction in data entry,
massive data collection,
remote monitoring.
Cost for connected
devices decreases
IoT technologies abound
enabling connectivity
with low power
and small form factor.
Increased focus
on security
Connected to cloud
will mean securely
connected or not
connected at all. Standards lag
behind innovation
New ideas will
come, new workflows
enabled all with desire
for interoperability.
Open architecture
and investment
Device companies will
publish architecture
and IT solutions
will support each one.
“Big Data”
“Wearables”
“Cloud”
“Move Fast”
“Innovators”

8. Page 7
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED
The Future Today – Phase 1 eSource integration
Challenge Solution
Provide integration of various devices from different
manufacturers into a common eSource platform – some
standards based interfaces, others with open
architecture APIs.
Leverage open architecture, make investments in
developing solutions to device APIs, use standards
where possible, understand workflow to maximize
benefit to customers.
Extensive investment required to maintain interfaces to individual APIs for an evolving and growing spectrum of
devices in the spirit of interoperability and customer delight.
Diagnostic ECG (ELI)
Telemetry Monitoring (Surveyor)
And more connections to more systems and devices as the goal
of interoperability is met…..

9. Page 8
© 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED WELCH ALLYN CONFIDENTIAL
Thank You
Justin L. Mortara, Ph.D.
justin.mortara@mortara.com